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Seborrheic dermatitis is a common and recurrent dermatosis that characteristically involves the scalp, nasolabial folds, eyebrows, glabella, and upper eye lids. It presents as an erythematous, thin scaly patch with a greasy sandpaper texture that varies depending on disease severity. While seborrheic dermatitis most frequently occurs on the face, it can involve other areas of the body especially the chest, abdomen, and axilla. Overall incidence is thought to be between 2-5% of the general population, though this is likely an underestimation. Pruritus is variable, though the signs and symptoms of this disorder are certainly worsened by certain external conditions especially weather, personal perspiration, stress, and poor hygiene. Patients often complain about the red, scaly patches on the face.
Antifungal agents are frequently used as monotherapy or in combination regimens in the treatment of seborrheic dermatitis. Topical corticosteroids are often used for their anti-inflammatory effects. Long term use of topical steroids on the face is not a preferred treatment modality due to the risk of striae development and other textural changes that occur over time. Therefore, topical crisaborole may be an alternative given its non-corticosteroid anti-inflammatory action. Crisaborole is a phosphodiesterase-4 (PDE-4) inhibitor that increases intracellular cyclic AMP (cAMP) levels to exert its anti-inflammatory effects. While it has not previously been investigated for its effects in seborrheic dermatitis, further studies evaluating its role in this disease are warranted.
Therefore, the investigators propose a proof of concept study using topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical crisaborole 2% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole | Drug | Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in ISGA (Investigator's Static Global Assessment) Score | • Investigator's Static Global Assessment (ISGA) is a skin assessment tool utilized in clinical trials. The tool is based on a 5-point scale with 0 or 1 (clear or almost clear) being the best score one could receive, while a score of 4 is the worst score available and indicates severe disease. ISGA will be collected via skin examination to evaluate efficacy of Crisaborole 2% topical ointment in the treatment of seborrheic dermatitis. A 0 or 1 (clear or almost clear) on the ISGA would be considered a treatment success. Percent change in ISGA score from baseline to 4 weeks will be measured and reported. | Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Itch NRS (Itch Numeric Rating Scale) | • The Itch Numeric Rating Scale (NRS) is a subject-administered, 11 point horizontal scale anchored at 0 and 10, 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a subject itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours. The Itch NRS (A numeric measurement of itch) will be collected to assess the percentage of improvement of patient reported itching. This will be calculated as a percent changes from baseline in the Itch NRS scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events That Are Related to Treatment. | Baseline to 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boni Elewski, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology at the Whitaker Clinic | Birmingham | Alabama | 35249 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Crisaborole 2% | Crisaborole: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Crisaborole 2% | Crisaborole: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in ISGA (Investigator's Static Global Assessment) Score | • Investigator's Static Global Assessment (ISGA) is a skin assessment tool utilized in clinical trials. The tool is based on a 5-point scale with 0 or 1 (clear or almost clear) being the best score one could receive, while a score of 4 is the worst score available and indicates severe disease. ISGA will be collected via skin examination to evaluate efficacy of Crisaborole 2% topical ointment in the treatment of seborrheic dermatitis. A 0 or 1 (clear or almost clear) on the ISGA would be considered a treatment success. Percent change in ISGA score from baseline to 4 weeks will be measured and reported. | One participant withdrew due to adverse events (headaches and facial pain) | Posted | Number | percent change | Baseline to 4 weeks |
|
Adverse event data were collected from the screening visit to the end of study visit for each participant, a total of 4 weeks per participant evaluation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Crisaborole 2% | Crisaborole: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Boni Elewski | University of Alabama at Birmingham | 205-502-9960 | dermresearch@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2018 | Jun 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C543085 | crisaborole |
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| Baseline to 4 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Itch NRS (Itch Numeric Rating Scale) | • The Itch Numeric Rating Scale (NRS) is a subject-administered, 11 point horizontal scale anchored at 0 and 10, 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a subject itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours. The Itch NRS (A numeric measurement of itch) will be collected to assess the percentage of improvement of patient reported itching. This will be calculated as a percent changes from baseline in the Itch NRS scale. | One participant withdrew due to adverse events (headaches and facial pain) | Posted | Number | percent change | Baseline to 4 weeks |
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events That Are Related to Treatment. | All enrolled patients were analyzed. | Posted | Count of Participants | Participants | Baseline to 4 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
| Facial Pain | General disorders | Non-systematic Assessment |
|
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| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |